Compliance for Proposals and Agreements (Non-Financial)

Contents

Understanding the potential impacts of non-fiscal regulatory compliance to specific projects at time of proposal or when reviewing agreements can help streamline eGC1 review and processing.

The eGC1 in SAGE requires eGC1 preparers to provide responses to a variety of non-fiscal compliance topics. OSP refers to campus responses to these questions during proposal and award review to ensure UW compliance with regulations and sponsor policies.

We highly recommend eGC1 preparers coordinate all responses to the non-fiscal compliance questions with the Principal Investigator and other members of the project team as needed. The eGC1 also allows you to send a direct link to sections of an eGC1 with the PI and Reviewers who have access to the eGC1.

The following compliance information was designed to help those preparing proposals and After-the-Fact eGC1s understand how to navigate specific non-fiscal compliance areas.

Does your project involve human subjects research?

Activities that meet the regulatory definition of human subjects research require either IRB review or a determination of exempt status. Information about the review process and requirements can be found on the Human Subjects Division website. Visit HSD’s Getting Started page if you have questions about whether review is required, you are new to human research, or you are new to the University of Washington.

Although most sponsors do not require IRB approval at the proposal stage, there are some human subjects requirements that are important to consider at this time:

• Use of a single IRB for multi-site or collaborative research requires prior approval and a letter of support from HSD. To request a letter of support, email hsdrely@uw.edu
• The UW Diversity in Clinical Trials policy applies to clinical trials submitted to HSD for either UW IRB or external IRB review on or after January 1, 2026, with some exceptions. The requirements of this policy will necessitate additional staff time and financial resources. It is important that you plan and budget for these.
• Other requirements for clinical trials also necessitate advance planning, such as data and safety monitoring, dissemination of clinical trial results, and special requirements for emergency medicine research for which consent is not possible.

Consult with the Human Subjects Division by emailing hsdinfo@uw.edu or by contacting the HSD staff team that serves your department.

Human Subjects Research and the eGC1 Questions

If you will have Human Subjects you must mark the Human Subjects question on the eGC1 (HS-1) with [YES].

At the proposal stage most sponsors do not require IRB approval.

Review guidance on Delayed Onset Human Research (DOHR). Answer [YES] to HS-1A on the eGC1, If the human subjects research:

• Will depend upon completion of significant pre-human subjects work
• For a clinical research that plans to add new protocols over the course of the award
• The award will fund specific projects that will be selected and funded by the awardee (e.g., a pilot project program; some training grants).

In most cases you can indicate IRB approval is pending on your eGC1 on HS-1B of the eGC1.

For federal and non-federal clinical trials: will the project involve use of UW Medicine clinical services or clinical space as a site of patient care, or include medical treatment of a patient by a UW Physicians provider? Mark eGC1 HS-1C [YES].

We recommend using the institutional REDCap Study Intake Form prior to completing the eGC1.

Benefits of using the Study Intake Form include:

• Determining if study entry into the OnCore Clinical Trial Management System (CTMS) is required for sponsor invoicing purposes, which helps answer the related eGC1 question correctly.
• Creating a study identifier number with the prefix “RG” that can be used in your eGC1 short title to help link up the study records.
• Helping to identify whether CTO review for budgeting and billing compliance purposes is required, and if so, to coincide with the study contract review.
• Connecting to additional clinical research resources (e.g., Investigational Drug Services, CTO Translational Research Unit, CTO Study Budget Negotiation, etc.), some of which may have an impact on contractual terms.

If human embryonic stem cells (hESC) will be used in the research, mark HS-2 [YES]. Review guidance from the Human Embryo and Embryonic Stem Cell Research Oversight Committee (ESCRO).

The hESC Committee provides scientific and ethical review of proposed human embryo and hESC research including compliance with applicable regulatory requirements and UW policies.

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Does your project involve animals?

Consult with the Office of Animal Welfare (OAW) by emailing oawrss@uw.edu to discuss:

• Capacity to work with the species of animal(s) that are identified in your research.
• Assistance in identifying and meeting space requirements for your animal work.
• Assistance with setting up protocols. The timeframe for approval of a new protocol is on average 3-4months from submission.

If the project involves work with vertebrate animals, cephalopods, or their tissues at UW or another performance site, Question AU-1 on the SAGE eGC1 must be marked [YES]. You will also need to identify whether the project is associated with a new Institutional Animal Care and Use Committees (IACUC) protocol or an existing one, and if an amendment to an existing protocol(s) is needed. Review Animal Use for assistance completing this section of the eGC1.

Note: All animal work must be approved on an IACUC protocol at the time of award for funds to be released. When an award is made:

• OAW uses this information to facilitate the required congruence review and establish any necessary agreements with collaborating institutions. Reach out to OAW if you have questions about what constitutes animal work or need assistance with protocol development.
• OSP uses this information to confirm there is an approved IACUC protocol(s) in place that applies to the project.

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Are there Environmental Health & Safety Considerations?

There will be institutional and sponsor requirements involving Environmental Health & Safety. Review the EH&S Introduction to Research Safety to understand important elements required for safety and compliance in your research space. Researchers and their teams should plan and apply for all necessary authorizations:

• Biological Use Authorization
• Bloodborne Pathogen Program
• Animal Use Medical Screening (AUMS)
• Radiation Use Authorization
• Radiation Producing Devices
• Laser Safety

Review the EH&S Guide for Principal Investigators for more information.

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Will the project involve Equipment & Materials?

Will there be Equipment Fabrication?

Will the project involve equipment fabrication at the UW? You will need to identify equipment fabrication on the eGC1 in SAGE. Typically, equipment fabrication is exempt from F&A (F&A charged to individual line items for equipment fabrication are 0%).

• Definition of equipment
• Fabrication Projects Job Aid: Job aid on Fabrication Projects in Workday specifically outlines responsibilities of key contacts and roles within the Workday Fabrication Project lifecycle. UW Net ID required to access.

Are you Exporting Items and/or Materials?

Will the project involve physically sending or taking hardware, equipment, specimens, goods, software, monies, biological or chemical materials out of the U.S. (excludes UW owned laptops and cell phones)? If Yes, you will need to describe the items/materials and list the destination country (or countries). This information will help the Export Controls Office determine if an export license may be required prior to being able to send or take the items/materials out of the U.S. Please reach out to exports@uw.edu if you have any questions about export compliance.

Are biological materials being provided to the sponsor or other non-UW parties? Materials include, but are not limited to, biological and related research materials such as cell lines, cultures, bacteria, nucleotides, proteins, transgenic animals, pharmaceuticals, or chemicals, and any associated data. Please review Sharing Material.

Sharing of any materials and/or data may require Material Transfer Agreements. Review Agreement Types.

Sharing proprietary or otherwise restricted information, technology or software with a foreign national may be subject to export control regulations and can occur at any time during your research. (Such as items found on a UW-owned laptop or cellphone). Please follow guidance found in the Data & Technology section that follows.

What about Data & Technology?

There are various regulatory requirements, sponsor restrictions, & UW policies to consider when data & technology are involved in sponsored projects. When these requirements are part of a proposal, you will need to provide more information explaining or describing what is involved in the project. The following sections provide basic information about some of these Data & Technology topics along with guidance on responding to the related eGC1 non-fiscal compliance questions.

Review More information on the following topics

• Proprietary Information
  • Confidential Information
  • Use of Intellectual Property (IP)
  • UW Background IP
  • Project IP and use of WIAP terms
• Classified or Restricted Research
• Restrictions on Publications or Foreign National Participation
• Projects with Military or Space Applications

Proprietary Information

Proprietary Information is information that a party or parties want to protect from disclosure and may involve Confidential Information and Intellectual Property (IP).

We need accurate details about Proprietary Information that will be shared or created on a project, however, information and documents included on an eGC1 are subject to public records requests.

When Proprietary Information is involved in a project, you must select either of the following on question D-1 of the eGC1:

• Proprietary non-technical information shared with the University of Washington.
• Export controlled/proprietary technical information or source code shared with the University of Washington that is not intended for publication.
  • Select this if UW may receive proprietary technical information or source code.
  • This is technical information or source code that is not the result of fundamental research / is not intended for publication or broad sharing within the research community.

Confidential Information:

If the project includes confidential information select the appropriate “Proprietary Information” checkbox on question D-1 on the eGC1.

Sharing confidential information, whether incoming or outgoing, will require terms in an agreement that protect the confidentiality of that information.

Use of Intellectual Property (IP):

At the proposal stage, the PI may be aware that the:

• Project will involve UW Background IP.
• UW will receive access to or make use of intellectual property (patent, copyright, or tangible property) from the sponsor or another party participating in the project.

UW Background IP:

When UW Background IP is part of a project, you must select “UW Background IP” on eGC1 question D-1. Projects that involve UW Background IP may influence whether the proposal can be submitted, or if submitted, what rights are available to the sponsor.

Background IP should not be used on the project unless:

• it is disclosed to CoMotion on the record of innovation form;
• the proposal specifies what the background IP is;
• it is specific to the project and the PI’s lab.

Project IP and use of WIAP terms:

If the Sponsor Type and/or Originating Sponsor Type is one of the following:

• Private Industry
• Private School, College, University
• Foreign Private Industry

The eGC1 will require you to respond to question T-1: Does the Sponsor wish to obtain an upfront commercial license to Project Intellectual Property (IP) based on the pricing under the Washington Innovation Advantage Program (WIAP)?

If an award is made, some industry sponsors may request certain upfront commercial licensing options. If you would consider any of the Washington Innovation Advantage Program (WIAP) licensing options to be incorporated into a resulting award, please answer [YES] to eGC1 question T-1.

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Classified or Restricted Research

Review Identifying Key Terms in Solicitations for help identifying if Classified, Restricted Information or Restricted Access Data will be part of the project. Some examples to watch for include references to NIST SP 800-171 or Basic Safeguarding of Contractor Information Systems 48 CFR 52.204-21.

Before you begin preparing a proposal or routing an eGC1 for projects that will:

• be handling Restricted Access Data, which can include federal contract information, or controlled unclassified information, you will need to follow the feasibility review & memo steps.
• include classified information please follow the Pre-Contract Requirements for Classified Research.

Question D-1 in the non-fiscal compliance section of the eGC1 requires you to select
Corresponding checkboxes. This applies to federal or federal flow-through funding from non-federal sponsors.

Review more details on Classified or Restricted Research in proposals at the UW.

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Restrictions on Publications or Foreign National Participation

request for proposal or project terms & conditions approval the Principal Investigator should complete a request for Faculty Council on Research restricted research proposal review.

Question D-3 on the eGC1 requires you to indicate if such restrictions exist. FCR approval is required before the UW can accept an award.

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Projects with Military or Space Applications or Sanctioned Countries

OSP will HOLD Proposal Submission & contact Office of Export Controls if the following eGC1 questions are answered [YES]:

D-2 Does this project or related items have known military/defense or space applications, or will you assist a foreign country’s military or space activities?

Answer [YES] if related technical information, software or physical items have known military/defense or space applications, even if all activities will take place in the U.S.

D-4. Will the project involve travel to or collaboration with a person or entity in a sanctioned country or region? (e.g., Cuba; Iran; North Korea; the following regions of Ukraine: Crimea, Donetsk, Luhansk)

Answer [YES] even if:

• The project is fundamental research.
• The UW is receiving items or information.
• ‘Only’ presenting at a conference.

Please contact exports@uw.edu if you have questions.

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What are non-fiscal compliance requirements impacting Personnel?

Significant Financial Conflict of Interest

SFI disclosures are required at the time of proposal for all individuals listed as an investigator on the eGC1. Review more information on Financial Interest Disclosures.

Debarment and Suspensions

PIs are required to make assurances on the eGC1 which include certifying that the PI and other Key Personnel have not been debarred, suspended, proposed for debarment, declared ineligible or voluntarily excluded from covered transactions by any federal department or agency.

Review GSA’s Suspension & Debarment FAQs

Malign Foreign Talent Recruitment Program (MFTRP)

UW individuals are prohibited from participating in Malign Foreign Talent Recruitment Program. Many federal sponsors also require individuals to certify they are not participating in these programs. See Foreign Interests in Sponsored Programs for guidance on MFTRP.

Required Training Completion

Make sure senior/key personnel named in a proposal have completed or are prepared to complete required training as soon as possible. Examples include:

• Research Security Training (when required, must occur before proposal submission)
• Other Support & Financial Conflict of Interest